Fast-dispersing dosage forms containing fish gelatin

a technology of fast-dispersing and fish gelatin, which is applied in the direction of pharmaceutical delivery mechanism, macromolecular non-active ingredients, peptide/protein ingredients, etc., can solve the problems of increasing processing times, increasing the overall cost of the process, and incurring heating costs

Inactive Publication Date: 2015-11-24
CATALENT USA WOODSTOCK INC +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0017]It has now been found that many of the problems associated with the use of mammalian-derived gelatin can be overcome if fish gelatin, especially non-gelling fish gelatin, is utilized for preparing fast-dispersing dosage forms. Surprisingly, the non-gelling form of fish gelatin from sources such as cold water fish, can be advantageously used in rapidly disintegrating dosage forms. Moreover, a number of further advantages have been identified in terms of processing parameters and the qualities of the resultant product.

Problems solved by technology

However, such mammalian derived gelatin has an unpleasant taste and thus necessitates the use of sweeteners and flavors in such fast-dispersing dosage forms to mask the taste of the gelatin in addition to any sweeteners and flavors which may be required to mask the taste of the active ingredient.
This heating step increases processing times and incurs heating costs thereby increasing the overall costs of the process.
While the prior art is replete with methods and techniques for the preparation of rapidly dispersing dosage forms, it has failed to consider the benefits associated with the use of fish gelatin, especially non-gelling, non-hydrolyzed fish gelatin, in such dosage forms.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of a Placebo Fast-Dispersing Dosage Form Using Fish Gelatin

[0079]Spray-dried fish gelatin (4 g) and mannitol (3 g) were added to a glass beaker. Purified water (93 g) was then added and solution effected by stirring using a magnetic follower. No heating was required. A Gilson pipette was then used to deliver 500 mg of this solution into each one of a series of pre-formed blister pockets having a pocket diameter of about 16 mm. The blister laminate comprised PVC coated with PVdC. The dosed units were then frozen at a temperature of −110° C. in a freeze tunnel with a residence time of 3.2 minutes and the frozen units were then held in an upright freezer for a time greater than 1.5 hours at a temperature of −25° C. (±5° C.). The units were then freeze-dried overnight with an initial shelf temperature of −10° C. rising to +20° C. at a pressure of 0.5 mbar. The units were checked for moisture prior to unloading by the drying trace and by the pressurized moisture check. The re...

example 2

Comparative Tensile Strength and Dispersion Testing

[0088]The units produced in Example 1 and the Comparative Examples A through C were subjected to tensile strength and disintegration tests according to methods conforming to the USP monograph requirements. An additional dispersion test was also carried out to identify any subtle differences which may not be apparent from the disintegration test.

[0089]The dispersion test was performed by adding 500 ml volume of purified water into a glass beaker. The water was then heated to a temperature of 37° C. The units were carefully dropped onto the surface of the water and the time taken to fully disperse noted. The water was then changed for subsequent unit testing.

Results

[0090]The units produced in Example 1 exhibited a disintegration time of 0.85 seconds and gave a mean tensile strength value of 0.267 N mm−2. In contrast, the units produced in Comparative Example A exhibited a disintegration time of 4.28 seconds and had a mean tensile stre...

example 3

[0092]

Fast-Dispersing Dosage Form using Fish Gelatin withDextromethorphan as the Active Ingredient% by weight ofIngredientWeight (mg)compositionPurified water* EP / USP909.090.9Fish gelatin40.04.0Mannitol EP / USP30.03.0Aspartame EP / USNF**4.00.4Mint Flavor2.00.2Dextromethorphan HBr15.01.5TOTAL1000.0100.0*signifies removal during the lyophilization process.**USNF = United States National Formulary

[0093]A mean Tensile strength value of 0.206 N mm2 was obtained for these dosage forms, with a disintegration time of 0.78 seconds.

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Abstract

The invention disclosed herein relates to a pharmaceutical composition comprising a carrier and an active ingredient, wherein the carrier is fish gelatin and the composition is a fast-dispersing dosage form designed to release the active ingredient rapidly on contact with a fluid. In one embodiment, the composition is designed for oral administration and releases the active ingredient rapidly in the oral cavity on contact with saliva. The fish gelatin can be obtained from cold water fish sources and is preferably the non-gelling, non-hydrolyzed form. A process for preparing such a composition and a method of using fish gelatin in a fast dispersing dosage form are also provided.

Description

RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 09 / 959,018, filed Oct. 16, 2001 and now U.S. Pat. No. 6,709,669 issued Mar. 23, 2004, which is a 371 filing from International Application No. PCT / US00 / 09278 filed Apr. 7, 2000 and claims priority to GB 9908014.5 filed Apr. 8, 1999.TECHNICAL FIELD[0002]This invention relates to fast-dispersing pharmaceutical compositions. In particular, the invention relates to freeze-dried fast-dispersing dosage forms containing fish gelatin.BACKGROUND OF THE INVENTION[0003]Fast-dispersing dosage forms which are designed to release the active ingredient in the oral cavity are well known and can be used to deliver a wide range of drugs. Many such fast-dispersing dosage forms utilize gelatin as a carrier. Gelatin B. P., which is normally utilized in such formulations, is defined as a protein obtained by partial hydrolysis of animal collagenous tissues such as skin, tendons, ligaments and bones, with boili...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): A61K9/20A61K9/00A61K47/42A61K9/19A61K9/22A61K9/64A61K47/18A61K47/26
CPCA61K9/2063A61K9/0056A61K47/42A61K9/20
Inventor GREEN, RICHARDMURRAY, OWENHALL, MICHAELKEARNEY, PATRICK
Owner CATALENT USA WOODSTOCK INC
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